Study of Molecular Status and Safety of Fluorodeoxyglucose 18F-FDG in PET-CT Imaging for Children and Teens with Histiocytosis

What this Trial Is About

This research aims to improve diagnosis for children with histiocytosis by analyzing the molecular characteristics of tumor tissues and monitoring these markers in circulating DNA. It also evaluates the usefulness and safety of fluorodeoxyglucose 18F-FDG in PET-CT scans to detect the disease. The study is part of the POLHISTIO project, focusing on better understanding and treating juvenile histiocytosis by linking molecular test results with clinical data and known prognostic factors. Participants receive fluorodeoxyglucose 18F-FDG as part of PET-CT imaging, with dosing up to a maximum of 6 MGBqkg but not exceeding 100 MGBq. The study is a low intervention, open-label trial conducted at a single center, including children under 18 years old with confirmed or suspected histiocytosis. Researchers will also develop a cell line from patient samples to study disease mechanisms and drug responses. Throughout the study, children will undergo molecular testing of tumor tissue and blood for circulating DNA markers, along with PET-CT imaging using fluorodeoxyglucose. The study will monitor event-free survival over two years as the main outcome, along with overall survival and detection of molecular relapse. Safety and diagnostic effectiveness of the imaging agent will also be assessed. Participation involves regular clinical evaluations and laboratory tests over the study period, which extends up to two years for outcome tracking.

Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging